Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:47 AM
Ignite Modification Date: 2025-12-26 @ 10:20 AM
NCT ID: NCT04718961
Description: Part 2 was early terminated due to lack of enrollment and the company's assessment of enrollment feasibility.
Frequency Threshold: 0
Time Frame: All adverse event data will be collected from first dose of study drug at baseline until whichever of the following time points comes last: 28 days after delivery, or up to 30 days after date of discharge from hospital for mother or for baby, **up to 25 weeks**
Study: NCT04718961
Study Brief: A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1 Arm 2 - Volixibat 80mg (Experimental) Participants randomized to this arm will receive volixibat 80mg twice daily. Volixibat: Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor. 0 None 0 2 2 2 View
Part 2 Arm 1 - Volixibat Selected Dose mg (Experimental) Participants randomized to this arm will receive volixibat selected dose (mg) twice daily. Volixibat: Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor. 0 None 0 0 0 0 View
Part 2 Arm 2 - Placebo (Placebo Comparator) Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily. Placebo: Oral capsules, administered twice daily. Capsules matched to study drug minus active substance. 0 None 0 0 0 0 View
Part 1 Arm 1 - Volixibat 20mg (Experimental) Participants randomized to this arm will receive volixibat 20mg twice daily. Volixibat: Oral capsules, administered twice daily. Volixibat is an ileal bile acid transporter (IBAT) inhibitor. 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postnatal Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Premature Labor SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Raised Blood Pressure SYSTEMATIC_ASSESSMENT Investigations None View
Threated Pre-Term Labor SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Apnoic Episodes SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heart Burn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intermittent Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intermittent Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intermittent Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View